What DUAL I measured first
| IDegn=413 | IDegLiran=833 | Liraglutiden=414 |
|---|---|---|
| -1.44(1.03) | -1.91(1.07) | -1.28(1.13) |
A 26 Week Randomised, Parallel Three-arm, Open-label, Multi-centre, Multinational Treat-to-target Trial Comparing Fixed Ratio Combination of Insulin Degludec and Liraglutide Versus Insulin Degludec or Liraglutide Alone, in Subjects With Type 2 Diabetes Treated With 1-2 Oral Anti-diabetic Drugs (OADs)With a 26 Week Extension
Mean Change From Baseline in HbA1c (Glycosylated Haemoglobin) at Week 26. (Percentage of glycosylated haemoglobin), Week 0, week 26. IDeg: -1.44; IDegLira: -1.91; Liraglutide: -1.28.
As posted on ClinicalTrials.gov (NCT01336023), updated at source Feb 19, 2018. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.
| IDegn=413 | IDegLiran=833 | Liraglutiden=414 |
|---|---|---|
| -1.44(1.03) | -1.91(1.07) | -1.28(1.13) |
Percent of participants affected, Adverse events (AEs) were collected from first day of exposure to randomised treatment of 52 weeks (26 week main period + 26 week extension period) + 7 days follow-up after the last day on randomised.... The most common events the registry lists.
| Event | IDeg | IDegLira | Liraglutide |
|---|---|---|---|
| Any serious event | 5.3% | 4.6% | 5.8% |
| Nausea | 3.9% | 10.3% | 22.3% |
| Diarrhoea | 6.8% | 10.2% | 16.3% |
| Headache | 10.9% | 12.8% | 14.6% |
| Nasopharyngitis | 12.6% | 13.9% | 13.3% |
| Vomiting | 2.4% | 5% | 9% |
| Lipase increased | 4.4% | 5.8% | 8.5% |
| Upper respiratory tract infection | 8.3% | 7.8% | 8% |
| Decreased appetite | 0.5% | 2.7% | 7.3% |
| Back pain | 4.9% | 5.5% | 5.6% |
| Dyspepsia | 1.2% | 3.4% | 5.3% |
| Arthralgia | 3.6% | 3.6% | 5.3% |
| Dizziness | 2.4% | 2.9% | 5.3% |
| Constipation | 1% | 3.2% | 5.1% |
| IDegn=413 | IDegLiran=833 | Liraglutiden=414 |
|---|---|---|
| 1.6(4.0) | -0.5(3.5) | -3.0(3.5) |
| IDegn=412 | IDegLiran=825 | Liraglutiden=412 |
|---|---|---|
| 256.7 | 180.2 | 22.0 |
| IDegn=63 | IDegLiran=128 | Liraglutiden=61 |
|---|---|---|
| -0.17(1.98) | -0.87(1.65) | -0.78(1.62) |
| IDegn=408 | IDegLiran=816 |
|---|---|
| 53(28) | 38(13) |
This trial is conducted globally. The aim of this trial is to compare the efficacy and safety of insulin degludec/liraglutide (IDegLira) versus insulin degludec (IDeg) and liraglutide (Lira) in subjects with type 2 diabetes. Subjects are to continue their pre-trial treatment with metformin or metformin + pioglitazone throughout the entire trial.
Inclusion Criteria: * Subjects with type 2 diabetes * HbA1c 7.0-10.0 % (both inclusive) with the aim of a median HbA1c of 8.3%. Accordingly, when approximately 50% of the randomised subjects have a HbA1c above 8.3%, the remaining subjects randomised must have a HbA1c of below or equal to 8.3%, or when approximately 50% of the randomised subjects have a HbA1c of below or equal to 8.3%, the remaining subjects randomised must have a HbA1c above 8.3% * Male or female, age 18 years or above (Taiwan: 20 years or above for a site 653 in Taiwan: Taichung Veterans General Hospital) * Subjects on stable dose of 1-2 OADs (metformin \[at least 1500 mg or max tolerated dose\] or metformin \[at least 1500 mg or max tolerated dose\] + pioglitazone \[at least 30 mg\]) for at least 90 days prior to screening * Body Mass Index (BMI) maximum 40 kg/m\^2 Exclusion Criteria: * Treatment with insulin (except for short-term treatment due to intercurrent illness at the discretion of the Investigator) * Treatment with GLP-1 (glucagon-like peptide-1) receptor agonists (eg exenatide, liraglutide), sulphonylurea or dipeptidyl peptidase 4 (DPP-4) inhibitors within 90 days prior to trial * Impaired liver function, defined as alanine aminotransferese (ALAT) at least 2.5 times Upper Normal Range (UNR) (one retest analysed at the central laboratory within a week from first sample taken is permitted with the result of the last sample being the conclusive) * Impaired renal function defined as serum-creatinine at least 133 mcmol/l (at least 1.5 mg/dl) for males and at least 125 mcmol/l (at least 1.4) for females, or as allowed according to local contraindications for metformin (one retest analysed at the central laboratory within a week from first sample taken is permitted with the result of the last sample being the conclusive) * Screening calcitonin at least 50 ng/L * Subjects with personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN 2) * Cardiac disorder defined as: congestive heart failure (NYHA class III-IV), diagnosis of unstable angina pectoris, cerebral stroke and/or myocardial infarction within the last 12 months and planned coronary, carotid or peripheral artery revascularisation procedures * Severe uncontrolled treated or untreated hypertension (systolic blood pressure at least 180 mm Hg or diastolic blood pressure at least 100 mm Hg) * Acute treatment required proliferative retinopathy or maculopathy (macular oedema) * History of chronic pancreatitis or idiopathic acute pancreatitis
Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.